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  • Regulatory NewsRegulatory News

    FDA Drafts Guidance on Heart Failure Treatment Endpoints

    As heart failure afflicts 6.5 million in the US, the Food and Drug Administration (FDA) on Thursday released draft guidance on the agency’s current thinking on developing drugs to treat heart failure. While noting that there are no effective treatments for heart failure with preserved ejection fraction (HFpEF), which represents about 50% of heart failure cases, FDA says up front that the 7-page draft has two purposes: to make clear that an effect on symptoms or physical...
  • Regulatory NewsRegulatory News

    FDA: Aspirin Manufacturers' Cardio Imagery is OK if Label Statement Included

    The US Food and Drug Administration (FDA) on Monday said that it does not intend to take action against certain manufacturers of over-the-counter (OTC) aspirin products because the label includes cardiovascular-related imagery (e.g., heart image, electrocardiography graphic, stethoscope around a heart image) if the label also includes language as described in guidance finalized Monday. "Because of the potential side effects associated with long-term aspirin therapy...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: CHMP Adopts Guidance on VTE Treatments (31 March 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Cardiovascular Working Party Signs off on Final Reflection Paper, Guidelines The Committee for Medicinal Products for Human Use (CHMP) has adopted a pair of final regulatory documents created by the Cardiovascular Working Party (CWP). Most significantly, the committee has adopted final guidelines on clinical trials of treatments for venous thromboembolism (VTE). Having bee...
  • Regulatory NewsRegulatory News

    FDA's 'TurboTax' Pilot Program for Medical Devices Expanding

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is expanding a new pilot program that it hopes will make medical device submissions a lot less complicated and a lot more like filing taxes using TurboTax. Background As explained by FDA in May 2014, its new 510(k) eSubmissions Program will help guide companies through the construction and submission of a premarket notification [510(k)] application, "eliminating the need for a ...
  • Regulatory NewsRegulatory News

    FDA Grapples With Lesser-Known Costs of Clinical Trials Transparency

    US medical device regulators soon plan to hold a public hearing to discuss how the results of cardiovascular outcomes trials (CVOTs) can be kept confidential until they are completed. Background The meeting, previewed by the US Food and Drug Administration (FDA) in a 14 July 2014 Federal Register notice, comes after years of the agency placing more of an emphasis on mandatory post-market approval trials. Those trials are meant to assuage outstanding regulatory concer...
  • French Regulators find Cardiology Manufacturer Non-Compliant with Regulations, Withdraw Devices

    • 15 May 2013
    French regulator ANSM has announced yet another problem-the second in as many weeks following a major scandal in 2012-this time with the Jarvik 2000 heart device due to violations of French laws and regulations by a manufacturer in the country. Background ANSM-Agence nationale de sécurité du médicament et des produits de santé, for those who prefer the full title-is a recent addition  to the world regulatory stage, having only been cr...
  • New EMA Guideline on Diabetes Focuses on Cardiovascular Risks

    The European Medicines Agency (EMA) has released a new guideline aimed at assisting sponsors in the development of products to treat or prevent diabetes mellitus. The guideline makes important changes to how the agency plans to assess the cardiovascular risk of diabetes products and its "high-level" approach to emerging diabetes products. The new guideline, On Clinical Investigation of Medicinal Products in the Treatment or Prevention of Diabetes Mellitus , updates a pr...
  • Feature ArticlesFeature Articles

    Pythons—A Model to Study Human Heart Disease?

    • 15 June 2012
    Many of my previous articles for RAPS have featured a host of disparate animals that are or could be used in medicine or in medical research, including leeches, maggots, rats, spiders, whipworms, Gila monsters and zebrafish. Now, there is new evidence to include Burmese pythons on this distinguished list. This snake species may be used to develop drugs to treat human heart disease. 1 In anticipation of this event, it would be prudent to know more about  Burmese pyth...
  • Advisory Committee Votes Against Label Expansion for J&J/Bayer's Xarelto

    The US Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee voted against Johnson & Johnson and Bayer's co-developed oral anticoagulant drug Xarelto (rivaroxaban), which the companies were looking to market as a therapy for Acute Coronary Syndrome (ACS). Xarelto is already FDA-approved for reducing the risk of blood clots in limited populations. The advisory committee had expressed some doubts regarding the drug on 22 May, saying m...
  • Reviewers Express Doubts in Advance of Xarelto Review

    An advisory committee to the US Food and Drug Administration (FDA) gave US-based manufacturer Johnson & Johnson's (J&J) blood thinner Xarelto (rixaroxaban), experimentally used to treat acute coronary syndrome (ACS), mixed reviews after taking issue with the quality of data used to support the drug. CNBC reports the panel of advisors was particularly troubled by missing data , including 12% of patients in the study and several deaths which were not counted in ...
  • FDA Issues New Recommendations for MS Drug After Cardiovascular Concerns Raised

    The US Food and Drug Administration (FDA) has placed new contraindications on Novartis' Multiple Sclerosis drug Gilenya (fingolimod) after investigating the cases of several patients who died soon after taking the drug. FDA said it had completed an investigation into the adverse event reports, and while it "could not definitely conclude that Gilenya was related to any of the deaths," it remained "concerned about the cardiovascular effects of Gilenya after the first dose....
  • Reuters: French Regulatory Authority, Executives Searched In Mediator Probe

    • 03 February 2012
    The offices of French regulatory authority Afssaps were searched by French investigators on 2 February as part of an investigation in to deaths associated with Servier's anti-diabetes drug Mediator, according to Reuters . Mediator has been blamed for over 500 deaths in France, and was on the market for more than 30 years. After its introduction to the market in 1976, it was prescribed to nearly 5 million French citizens before it was recalled from the market in late 200...